The Food and Drug Administration Globalization Act of 2008

Transcription

1 Covington & Burling llp Brussels London New York San Francisco Washington Food & Drug E-Alert The Food and Drug Administration Globalization Act of 2008 April 24, 2008 On April 17, 2008, Representative Dingell, Chairman of the Committee on Energy and Commerce ( E&C Committee ) of the U.S. House of Representatives, circulated to Committee members a discussion draft bill entitled the Food and Drug Administration Globalization Act of 2008 (the draft bill ). 1 The draft bill would amend the Federal Food, Drug, and Cosmetic Act ( FDCA ) (21 U.S.C. 301 et seq.) and is intended to enhance the safety standards governing foods, cosmetics, and other products regulated by the Food and Drug Administration ( FDA ). This memorandum addresses the provisions of the draft bill that, if enacted, would apply to food and cosmetic products. According to the letter from Reps. Dingell, Pallone, and Stupak accompanying the discussion draft bill, the legislation is designed to build upon H.R. 3610, the Food and Drug Import Safety Act of 2007 (introduced by Rep. Dingell on September 20, 2007), H.R. 3624, the Consumer Food Safety Act of 2007 (introduced by Rep. Pallone on September 20, 2007), H.R. 3115, the Carbon Monoxide Treated Meat, Poultry, and Seafood Safe Handling, Labeling, and Consumer Protection Act (introduced by Rep. Stupak on July 19, 2007), and H.R. 3484, the Safe and Fair Enforcement and Recall for Meat, Poultry, and Food Act of 2007 (introduced by Rep. DeGette on September 6, 2007). The draft also is intended to build upon the investigations conducted by the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce, the report of the FDA Science Board s Subcommittee on Science and Technology, 2 FDA s Food Protection Plan, 3 the Interagency Import Safety Plan, 4 and account for views of key stakeholders. The letter indicates that the E&C Committee plans to conduct hearings on the draft bill during the next few weeks, and to markup the legislation soon after the hearings are completed. I. Food Safety A. Expanded Registration Requirements for Food Facilities: Amends Section 415 of the FDCA and Adds Proposed Section 741 to the FDCA The draft bill would expand registration requirements for food facilities, requiring that each facility that is engaged in manufacturing, processing, packing, or holding food for consumption in the United States 5 be registered and subsequently reregistered on an annual basis and pay facility 1 This memorandum is based on the discussion draft stamped April 16, 2008 (12:05 p.m.). 2 FDA Science and Mission at Risk, Report of the Subcommittee on Science and Technology, Prepared for FDA Science Board (Nov. 2007), available at: 3 FDA, Food Protection Plan: An Integrated Strategy for Protecting the Nation's Food Supply (Nov ), available at: 4 The Interagency Working Group on Import Safety, Action Plan for Import Safety: A Roadmap for Continual Improvement (November 2007), available at: 5 These proposed requirements would apply to meat and poultry facilities. In addition, because the statutory definition of food includes finished articles of food intended for consumption as well as articles used for components of any such (continued ) C&B

2 registration fees in connection with each facility registration and reregistration required under the draft bill. 6 Under current law, registration is required only once for each food facility, and the registration must be updated to reflect any subsequent changes in the information submitted in the original registration. There is no requirement that facilities be reregistered annually or that facility registration fees be paid. The draft bill would require companies to pay registration fees amounting to $2,000 for each initial registration and reregistration of each food facility operated by the applicant, and fees would be adjusted to account for inflation. 7 Failure to comply with registration requirements or pay registration fees would constitute prohibited acts under section 301 of the FDCA. 8 In addition, the draft bill would require the Secretary to remove from its list of registered facilities the name of any facility that fails to comply with reregistration requirements, and treat the removal as a suspension of the facility s registration. 9 These proposed requirements represent a major change in the law and go far beyond what is even currently required for the registration of drug products under section 510 of the FDCA, which is a ministerial requirement. 10 Under FDCA section 415(a)(3), the Secretary is required to assign a registration number to each registered food facility. The draft bill would amend section 415(a)(3) to require that the registration number be a unique identification number that may be used for purposes other than registration under section article (i.e., ingredients or additives), these proposed requirements would apply to ingredient or food additive manufacturers, processors, packers, or holders. See FDCA 201(f). 6 Section 101(b)(1), Discussion Draft (amending section 415(a) of the FDCA). The draft bill would also require that commercial importers of food that are not registered under section 415 be registered with the Secretary and pay a registration fee. Section 401, Discussion Draft (adding sections 801(s) and 742 to the FDCA). Essentially all of these requirements would also extend to cosmetics. See Section II of this memorandum. 7 Section 101(b)(2), Discussion Draft (adding section 741(b)(1) to the FDCA). The draft bill would limit the annual increase in fee to the amount of such fee for the previous fiscal year increased by the same percentage inflation adjustment described in FDCA section 736(c)(1) for the applicable fiscal year. Section 101(b)(2), Discussion Draft (adding section 741(b)(2)(A) to the FDCA). The draft bill also would prohibit the Secretary from increasing the amount of the registration fee after FY2009 unless the amount appropriated for salaries and expenses of the Center for Food Safety and Applied Nutrition (CFSAN) for the given fiscal year were equal to or greater than the amount appropriated for CFSAN salaries and expenses for FY2008 multiplied by the inflation adjustment factor for the applicable fiscal year under section 736(c), and the amount appropriated for FDA salaries and expenses for the given fiscal year were equal to or greater than the amount appropriated for FDA salaries and expenses for FY2008 multiplied by the inflation adjustment factor for the applicable fiscal year under section 736(c). For purposes of determining the amounts appropriated for FDA salaries and expenses, the Secretary would exclude user fees collected in connection with drug, medical device, and animal drug applications. For purposes of determining both CFSAN and FDA salaries and expenses, the Secretary would not take into account those salaries and expenses that were paid from user fees collected in connection with drug, medical device, and animal drug applications, or from certifying agent fees, or food and animal feed export certification fees. Section 101(b)(2), Discussion Draft (adding section 741(b)(2)(B) to the FDCA). 8 Section 101(a), Discussion Draft (amending section 301(p) of the FDCA). 9 Section 101(b)(1), Discussion Draft (amending section 415(a) of the FDCA). 10 The draft bill would require, however, that the Secretary assess and collect an annual fee from the entities that are required to register with the Secretary under section 510 of the FDCA: (1) any person who owns or operates an establishment in the United States engaged in manufacturing a drug; and (2) any establishment within a foreign country engaged in manufacturing a drug that is imported or offered for import into the United States. Section 201(b), Discussion Draft (adding section 736C to the FDCA). 11 Section 402(a), Discussion Draft (amending section 415(a)(3) of the FDCA). This amendment applies to cosmetics through the operation of section 604 of the FDCA. Section 402(c), Discussion Draft. Page 2

3 The draft bill would amend FDCA section 415(a)(2) to expand the information companies would be required to submit to register a food facility. Under the proposed amendments, the required information would include the following: The name, address, and emergency contact information of each facility engaged in the manufacturing, processing, packing, or holding of food for consumption in the United States that the registrant operates. The primary purpose and business activity of each such facility, including the dates of operation if the facility is seasonal. The general food category (as listed under section 170.3(n) of title 21, Code of Federal Regulations, or as the Secretary may otherwise designate for purposes of evaluating potential threats to food protection) of any food manufactured, processed, packed, or held at each such facility. All trade names under which each such facility conducts business related to food. The name, address, and 24-hour emergency contact information of the United States distribution agent for each such facility, which agent shall maintain information on the wholesale and retail distribution of food. An assurance that the registrant will notify the Secretary of any change in the products, function, or legal status of each facility (including cessation of business activities) no later than 30 days after the date of such change. 12 The draft bill would authorize the Secretary to suspend the registration of any facility registered under this section, including the facility of an importer, for violation of the act that could result in serious adverse health consequences or death to humans or animals, or if the facility, or employee of the facility, delays, limits, or denies inspection by the Secretary. 13 The Secretary would be required to provide notice to the registrant of the intent to suspend the registration and provide an opportunity for an informal hearing. 14 The draft bill would direct the Secretary to publish criteria for reinstatement of a registration in the Federal Register or on the FDA website. 15 The draft bill would allow any registrant whose registration is suspended to appeal that action in any appropriate federal district court. 16 These provisions would take effect no later than 60 days after the date of enactment Section 101(c), Discussion Draft (amending section 415(a)(2) of the FDCA). The draft bill would require that the Secretary modify the existing registration form within 30 days after the date of enactment. Section 101(e)(1), Discussion Draft. 13 Section 101(d), Discussion Draft (adding section 415(a)(6)(A) to the FDCA). 14 Section 101(d), Discussion Draft (adding section 415(a)(6)(B) to the FDCA). 15 Section 101(d), Discussion Draft (adding section 415(a)(6)(C) to the FDCA). 16 Section 101(d), Discussion Draft (adding section 415(a)(6)(D) to the FDCA) 17 Section 101(e)(2), Discussion Draft. Page 3

4 B. Food Safety Plans: Adds Proposed Section 418 to the FDCA The draft bill would require the owner, operator, or agent in charge of any registered facility to develop and implement a written food safety plan for a food facility ( food safety plan ) before introducing or delivering for introduction into interstate commerce any shipment of food from a food facility. 18 This requirement would take effect 2 years after the date of enactment. 19 The draft bill would require the food safety plan to be based on an analysis of the specific practices for (1) obtaining and ensuring the safety of raw materials and ingredients for food produced, manufactured, processed, packed, or held at a facility; (2) producing, manufacturing, processing, packing, and holding food at the facility; and (3) transporting food to and from the facility. The plan would also be required to account for any hazard that has been present in or on, or is reasonably likely to be present in or on, any food that is manufactured, processed, packed, or held at the facility. 20 The draft bill would require that the food safety plan contain five elements to mitigate and monitor hazards: (1) a description of the preventive controls being implemented that are reasonably appropriate to control or limit identified hazards and to comply with applicable hazard-specific performance standards and other food safety requirements; (2) validation that such preventive controls are effective to reduce, control, or eliminate such hazard; (3) a description of monitoring such preventive controls being implemented, including sampling and testing relating to the control of hazards where appropriate to verify that the controls are effective; (4) a description of the recordkeeping being conducted, including evidence of corrective actions, sampling and testing records, monitoring and verification records, and validation records; and (5) a description of established procedures for the recall of such articles of food, whether voluntarily or when required under section The Secretary would be authorized to require that a food safety plan include specific hazard controls, if such controls are needed to ensure the protection of the public health including to prevent intentional adulteration of food. 22 The draft bill would require that the food safety plan be revised when major changes have been made by the owner of the facility and as deemed appropriate by the Secretary. 23 The draft bill would authorize the Secretary to review the food safety plan during mandatory inspections of the facility. 24 The draft bill would authorize the Secretary to establish by regulation and enforce performance standards that define, with respect to specific foods and contaminants in food, the level of food safety performance that a facility shall meet. 25 In establishing these standards, the Secretary would be required to consult with the Centers for Disease Control and Prevention and infectious disease experts outside the government and hold public meetings for public input and comment Section 102(a), Discussion Draft (adding section 418(a)(1) to the FDCA). 19 Section 102(b), Discussion Draft. 20 Section 102(a), Discussion Draft (adding sections 418(a)(1)(A), (B) to the FDCA). 21 Section 102(a), Discussion Draft (adding section 418(a)(2) to the FDCA). 22 Section 102(a), Discussion Draft (adding section 418(b)(2) to the FDCA). 23 Section 102(a), Discussion Draft (adding section 418(b)(1) to the FDCA). 24 Section 102(a), Discussion Draft (adding section 418(c) to the FDCA). 25 Section 102(a), Discussion Draft (adding section 418(d)(1) to the FDCA). 26 Section 102(a), Discussion Draft (adding section 418(d)(2) to the FDCA). Page 4

5 C. Safety Standards for Fresh Produce: Adds Proposed Section 419 to the FDCA The draft bill would authorize the Secretary to issue regulations specifying the manner in which a producer of a type of fresh produce may comply with section 418. Section 418 would apply to the production of such a type of fresh produce 1 year after the Secretary issues the regulations. 27 If the Secretary issues a regulation with respect to the production of a type of fresh produce, the draft bill would require that the Secretary provide for a variance from such regulation for producers in a State or foreign country if the State or foreign country determines, and the Secretary concurs, that the variance is necessary given local growing conditions, and that it will be at least as effective in controlling hazards as if the variance had not been provided. 28 D. Inspection of Food Facilities: Adds Proposed Sections 704A and 741A to the FDCA The draft bill would require the Secretary to conduct unannounced inspections of facilities every four years, except that inspections of facilities that are not certified under section 420 would be required to occur every 2 years. 29 The Secretary would be required to determine if the facilities were operating in compliance with the act, including with respect to good manufacturing practices and section 419 requirements for fresh produce. The Secretary would be authorized to review and copy records, inspect the facility or vehicle and all pertinent equipment, materials, containers, labeling, processes, controls, and premises, and collect and retain samples of food products or ingredients. 30 Currently, FDA has no explicit statutory authority to review food production records and has limited authority to review distribution records. Within 24 hours after completing the inspection, the Secretary or accredited certifying agent making the inspection would be required to provide a written report setting forth any conditions or practices observed which indicate that either processing controls are inadequate to prevent or minimize food safety hazards or that any food from such facility is unsafe for human consumption, or adulterated or misbranded under the act. 31 If a facility or employee of a facility delays, limits, or denies an inspection, the draft bill would authorize the Secretary to make a determination that may result in the facility losing its registration under section The draft bill would authorize the Secretary to order a food product segregated, impounded, and if objection is not made within 48 hours, condemned, if during an inspection, the Secretary or certifying agent has reason to believe that a food product is unsafe for human or animal consumption or adulterated or misbranded under the act. 33 The draft bill would authorize the Secretary 27 Section 103, Discussion Draft (adding section 419(a) to the FDCA). The Secretary would be required to assist a State or foreign country in identifying how, considering local growing conditions, producers in the State or foreign country may comply with section 418. Section 103, Discussion Draft (adding section 419(b) to the FDCA). 28 Section 103, Discussion Draft (adding section 419(c) to the FDCA). 29 Section 104(a), Discussion Draft (adding section 704A(a) to the FDCA). The text of the draft refers to certification under section 418, but this reference appears to be an error, as section 418 relates to food safety plans, and section 420 describes the food facility certification program. 30 Section 104(a), Discussion Draft (adding sections 704A(b)(1), (2) to the FDCA). 31 Section 104(a), Discussion Draft (adding section 704A(b)(3) to the FDCA). 32 Section 104(a), Discussion Draft (adding section 704A(a)(3) to the FDCA). 33 Section 104(a), Discussion Draft (adding section 704A(c)(1) to the FDCA). If objection is made, such food products that are in perishable form would be processed to the extent necessary to avoid spoilage, and a hearing would be commended. Id. These proposed provisions would not require that this order be made or approved by an employee at a certain level within (continued ) Page 5

6 to release such food product if the Secretary determines that such food product can be brought into compliance with the act through re-labeling or other action and that such re-labeling or other action has been performed. 34 Any food condemned without objection, or after an informal hearing, would be required to be destroyed. 35 The draft bill would require the Secretary to assess and collect fees (a reinspection fee ) from each facility that during a fiscal year commits a violation of any requirement of the act related to food and because of such violation, undergoes additional inspection by FDA. 36 The amount of fees assessed would be set to fully defray the costs of conducting these additional inspections, and the Secretary would be required to make all fees collected pursuant to this section available only to pay for the costs of additional inspections. 37 E. Food Facility Certification Program: Adds Proposed Sections 420 and 741B to the FDCA The draft bill would require the Secretary to establish a voluntary program that would certify a facility (domestic and foreign) as being in compliance with the applicable requirements of the act. The program would allow for direct certification by the Secretary and certification by an accredited certifying agent. 38 The Secretary or certifying agent would be required to inspect the facility before certification. 39 The draft bill would authorize the Secretary to suspend a facility s certification if, after opportunity for an informal hearing, the Secretary determines that the facility s food safety plan fails to comply with section 418 or the facility is found not to be in compliance with other applicable requirements. 40 The certification would be effective for 2 years, 41 and the Secretary would be required to make available to the public through the internet a list of each certified facility and the date on which such certification expires. 42 The draft bill would require the Secretary, no later than 2 years after the date of enactment, to establish and implement an accreditation system under which a foreign government, a State, or regional food authority, a foreign or domestic cooperative that aggregates the products of growers or processors, or any other appropriate third party may request permission to certify facilities under section The draft bill would require FDA to review and audit any foreign government or the agency, for example by an official at the district director level or higher. In contrast, the administrative detention provisions added by the Bioterrorism Act of 2002 require that a detention under those provisions be approved by an official at the district director level or higher. See FDCA 304(h)(1)(B). Also, the draft bill does not provide a procedure for implementing these provisions. 34 Section 104(a), Discussion Draft (adding section 704A(c)(2) to the FDCA). 35 Section 104(a), Discussion Draft (adding section 704A(c)(3) to the FDCA). 36 Section 105(a), Discussion Draft (adding section 741A(a) to the FDCA). 37 Section 105(a), Discussion Draft (adding sections 741A(b), (c) to the FDCA). 38 Section 106(a), Discussion Draft (adding section 420(a) to the FDCA). 39 Section 106(a), Discussion Draft (adding section 420(b)(3) to the FDCA). 40 Section 106(a), Discussion Draft (adding section 420(b)(5) to the FDCA). 41 Section 106(a), Discussion Draft (adding section 420(b)(2) to the FDCA). 42 Section 106(a), Discussion Draft (adding section 420(b)(1) to the FDCA). 43 Section 106(a), Discussion Draft (adding section 420(c) to the FDCA). Page 6

7 third party (including the food safety programs, systems, and standards, and the training and qualifications of inspectors used by the agent) to determine that they are adequate to ensure that the facilities certified by such body meet the requirements of the act. 44 As a condition of accreditation, the foreign government or third party would be required to agree to issue a written and electronic certification to accompany each food shipment made for import from a facility certified by such agent, subject to the recommendations set forth by the Secretary. 45 The draft bill would authorize the Secretary to conduct an on-site audit of any facility certified by the agent or require the agent to submit to the Secretary, for any facility certified by the agent, an on-site inspection report and any other reports or documents required as part of the audit process. 46 The Secretary would be authorized to withdraw accreditation from a certifying agent if food from facilities certified by such agent is linked to an outbreak of human or animal illness; or the Secretary determines that the agent no longer meets the requirements for accreditation, or the agent refuses to allow United States officials to conduct necessary audits and inspections. 47 The draft bill would allow the Secretary to set, assess, and collect a fee for the accreditation of a foreign government or third party as a certifying agent. 48 F. Testing of Food Shipments: Adds Proposed Sections 421 and 741C to the FDCA The draft bill would require any non-certified facility to arrange for an accredited laboratory to sample and test any shipment of food before introducing or delivering for introduction into interstate commerce to ensure compliance with the applicable food safety standards. The accredited laboratory would be required to simultaneously submit electronically the results of such sampling and testing to the Secretary and the owner of such facility. 49 Failure to comply with this requirement would constitute a prohibited act under section 301 of the FDCA. 50 A certified facility would be required to arrange for an accredited laboratory to conduct, on a periodic basis specified by the Secretary, sampling and testing of shipments of food being introduced or delivered for introduction into interstate commerce to ensure compliance with applicable food safety standards. The accredited laboratory would be required to simultaneously submit electronically the results of such sampling and testing to the Secretary and the owner of such facility. 51 The draft bill would require the Secretary to establish and publish in the Federal Register, within 1 year of the date of enactment, standards to accredit or deny accreditation to laboratories. 52 The laboratory would be required to pay the annual accreditation fee to defray the costs of the accreditation activities. 53 The draft bill would require the Secretary to make annual onsite visits 44 Section 106(a), Discussion Draft (adding sections 420(c)(2), (3) to the FDCA). 45 Section 106(a), Discussion Draft (adding section 420(d) to the FDCA). 46 Section 106(a), Discussion Draft (adding section 420(e) to the FDCA). 47 Section 106(a), Discussion Draft (adding section 420(h) to the FDCA). 48 Section 106(b), Discussion Draft (adding section 741B to the FDCA). 49 Section 107(b), Discussion Draft (adding section 421(a) to the FDCA). 50 Section 107(a), Discussion Draft (adding section 301(oo) to the FDCA). 51 Section 107(b), Discussion Draft (adding section 421(b) to the FDCA). 52 Section 107(b), Discussion Draft (adding section 421(c) to the FDCA). 53 Section 107(c), Discussion Draft (adding section 741C to the FDCA). Page 7

8 to each accredited laboratory to audit the performance of such laboratory and to take such additional measures as the Secretary determines to be appropriate. 54 These provisions would take effect no later than 3 years after the date of enactment. 55 G. Food Importation 1. Safe and secure food importation program: Adds proposed section 805 to the FDCA The draft bill would direct the Secretary, within 2 years of enactment, to develop voluntary safety and security guidelines for the importation of food. 56 The draft bill would require FDA to expedite the importation process of food from facilities that are certified under section 420 and meet these guidelines Imports and commercial food importation through specific ports of entry: Adds proposed section 422 to the FDCA The draft bill would restrict importation of all food to ports of entry in a metropolitan area with a federal laboratory, unless each facility that has manufactured, processed, packed, and held the food is certified under section This provision would take effect no later than 5 years after the date of enactment Research to enhance food safety test methods for imported food: Adds proposed section 801(p) to the FDCA The draft bill would require the Secretary to establish a research program (directly and/or through grants and contracts) to develop enhanced methods for the rapid detection of foodborne pathogens and toxins in imported food. 60 The draft bill would direct the Secretary to give greatest priority to the development of rapid test methods that are useful in the detection of intentional food adulteration, including specifically test methods for the detection of E. coli, salmonella, cyclospora, cryptosporidium, hepatitis A, Clostridium botulinum, or listeria, and the presence in or on food of pesticide chemicals, chemical toxins, pathogens, and any substance that the Secretary determines is a candidate for use to intentionally adulterate food. 61 The draft bill would require the Secretary to set 54 Section 107(b), Discussion Draft (adding section 421(c)(3) to the FDCA). 55 Section 107(d), Discussion Draft. 56 Section 108, Discussion Draft (adding section 805(a) to the FDCA). The draft bill would direct the Secretary to take the following factors into account in making the guidelines: (a) the personnel of the person importing the food; (b) the physical and procedural safety and security of such person s food supply chain; (c) the sufficiency of access controls for food and ingredients purchased; (d) the need for tracking and maintaining records on the food and ingredients purchased or moved through the supply chain; (e) documentation processing through the supply chain; (f) access by the Secretary to the business records for review; (g) vendor and supplier information; (h) other factors the Secretary determines necessary. Section 108, Discussion Draft (adding section 805(b) to the FDCA). 57 Section 108, Discussion Draft (adding section 805(a) to the FDCA). 58 Section 111, Discussion Draft (adding section 422 to the FDCA). 59 Id. 60 Section 112, Discussion Draft (adding section 801(p)(1) to the FDCA). 61 Section 112, Discussion Draft (adding section 801(p)(2) to the FDCA). Page 8

9 the goal of developing appropriate test methods for each of these microbiological and chemical hazards within 3 years after the date of enactment. 62 The draft bill would require the Secretary to submit to Congress periodic progress reports and research plans every six months, including updated estimates of the funding requirements necessary to meet the research goals the draft bill establishes. 63 The Secretary would be required to implement the required research program in consultation with the Centers for Disease Control and Prevention, the National Institutes of Health, the Environmental Protection Agency, and the United States Department of Agriculture Enforcement and recall: Adds proposed section 801(q)(1) to the FDCA The draft bill would authorize the Secretary to deny importation of food (other than only for personal use) from any foreign country or which is manufactured, processed, packed, or held by a facility if the government of such country, or such facility, does not timely consent to an investigation by FDA when food from that country or facility is linked to a food-borne illness outbreak or is otherwise found to be adulterated or mislabeled. 65 The draft bill would authorize FDA with respect to any food imported for consumption in the United States to detain and condemn such food pursuant to section 704A(c) of the FDCA or recall such food pursuant to section Registration and fee for commercial importer of food: Adds proposed sections 801(s) and 742 to the FDCA The draft bill would require the Secretary to issue regulations, no later than 1 year after the date of enactment, requiring that an importer of food, other than only for personal use, that is not registered under section 415, be registered with the Secretary in a form and manner specified by the Secretary. 67 Failure to comply with this requirement would constitute a prohibited act under section 301 of the FDCA. 68 The Secretary would be required to assign a unique identification number to each importer so registered 69 and would be required to assess and collect an annual fee ($10,000) for the registration. 70 H. Notification, Nondistribution, and Recall of Adulterated or Misbranded Food: Adds Proposed Section 423 to the FDCA The draft bill would require additional, enforceable reporting obligations and tools with respect to food. These new remedies would be in addition to any other remedies that might be available. 71 First, the draft bill would require any person (other than a household consumer or other 62 Section 112, Discussion Draft (adding section 801(p)(2)(C) to the FDCA). 63 Section 112, Discussion Draft (adding section 801(p)(3) to the FDCA). 64 Section 112, Discussion Draft (adding section 801(p)(4) to the FDCA). 65 Section 122, Discussion Draft (adding section 801(q)(1) to the FDCA). 66 Id. 67 Section 401(b), Discussion Draft (adding section 801(s) to the FDCA). This registration requirement and fee assessment would also apply to an importer of cosmetics that is not registered under section 604. Id. 68 Section 401(a), Discussion Draft (adding section 301(qq) to the FDCA). 69 Section 401(b), Discussion Draft (adding section 801(s) to the FDCA). 70 Section 401(c), Discussion Draft (adding section 742 to the FDCA). 71 Section 113(b), Discussion Draft (adding section 423(e) to the FDCA). Page 9

10 individual who is the intended consumer of an article of food) to notify the Secretary, as soon as practicable, of the identity and location of an article of food that the person has reason to believe is adulterated or misbranded (either when introduced into or while in interstate commerce or while held for sale after shipment into interstate commerce) in a manner that, if consumed, may result in illness or injury. 72 The draft bill would allow the Secretary to issue regulations defining the manner and means of this notification. 73 Failure to comply with this requirement would constitute a prohibited act under section 301 of the FDCA. 74 Second, the draft bill would require the Secretary, upon making a finding (based on either the notification or other means) that an article of food is adulterated or misbranded in a manner that, if consumed, may result in illness or injury, to provide all appropriate persons, including manufacturers, importers, distributors, or retailers of food, with an opportunity (as determined by the Secretary) (1) to cease distribution of the article; (2) to notify all persons that produce, manufacture, pack, process, treat, package, distribute, or hold the article or those persons to which the article has been distributed, transported, or sold to cease immediately those activities with respect to the article; (3) to recall the article; (4) in consultation with the Secretary, to provide notice of the finding of the Secretary to all consumers to which the article was, or may have been, distributed and to appropriate State and local health authorities; and (5) to notify State and local public health officials. 75 In addition, the draft bill would require the Secretary, as the Secretary determines to be necessary, to provide notice of this finding to consumers to which the article was, or may have been, distributed and to appropriate State and local health officials. 76 Third, the draft bill would require the Secretary, if the appropriate person does not carry out the action required by the Secretary within the time period and in the manner prescribed by the Secretary, to issue an order (a mandatory order ) requiring the appropriate person to immediately cease distribution of the article and to immediately notify all persons that produce, manufacture, pack, process, treat, package, distribute, or hold the article or those persons to which the article has been distributed, transported, or sold to cease immediately those activities with respect to the article. 77 The draft bill would authorize the Secretary to take control or possession of the article. 78 The draft bill would require that persons subject to a mandatory order be provided with an opportunity for a hearing, no later than 2 business days after the issuance date of the order, on the actions required by the order and any reasons why the article of food that is the subject of the order should not be recalled. 79 Failure to comply with the mandatory order following any hearing would constitute a prohibited act under section 301 of the FDCA. 80 Finally, the Secretary would be authorized to amend the mandatory order to require a product recall (including a timetable for the recall) or other appropriate action, provided that, after the 72 Section 113(b), Discussion Draft (adding section 423(a)(1) to the FDCA). 73 Section 113(b), Discussion Draft (adding section 423(a)(2) to the FDCA). 74 Section 113(a), Discussion Draft (adding section 301(pp)(1) to the FDCA). 75 Section 113(b), Discussion Draft (adding section 423(b)(1) to the FDCA). 76 Section 113(b), Discussion Draft (adding section 423(b)(3) to the FDCA). 77 Section 113(b), Discussion Draft (adding section 423(b)(2)(A) to the FDCA). 78 Section 113(b), Discussion Draft (adding section 423(b)(2)(B) to the FDCA). 79 Section 113(b), Discussion Draft (adding section 423(c) to the FDCA). 80 Section 113(a), Discussion Draft (adding section 301(pp)(2)(A) to the FDCA). Page 10

11 hearing, the Secretary determines that an article of food is adulterated or misbranded in a manner that, if consumed, may result in illness or injury. 81 The draft bill would allow the Secretary to require periodic reporting of the recall process and notice of such recall to consumers to which the article was, or may have been, distributed. 82 Failure to comply with the amended order would constitute a prohibited act under section 301 of the FDCA. 83 Alternatively, the draft bill would require the Secretary to vacate the mandatory order if, after the hearing, the Secretary determines that adequate grounds do not exist to continue the actions required by the order. 84 These provisions would take effect no later than 1 year after the date of enactment. 85 These proposed requirements are broader than the reporting and notification requirements mandated in the recently enacted Food and Drug Administration Amendments Act of 2007 ( FDAAA ). 86 For example, the draft bill would require that any person (other than an household consumer or other individual who is the intended consumer of an article of food, but including retailers) must report to FDA adulterated or misbranded food that, if consumed, may result in illness or injury, i.e., the equivalent of a Class I or II recall definition. In contrast, the reporting requirement in FDAAA is limited to a responsible party defined as a person that submits to FDA the food facility registration currently required under section 415(a) of the FDCA for the facility where the article of food at issue is manufactured, processed, packed or held who must report to FDA all reportable food ( an article of food for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals, i.e., a Class I recall definition) through the electronic Reportable Food Registry registry. 87 In addition, the draft bill would authorize FDA to issue mandatory recalls of adulterated or misbranded foods. The provisions in FDAAA do not provide this authority. I. Civil Penalties: Adds Proposed Section 303A to the FDCA The draft bill would add new civil penalties relating specifically to food. Under the draft bill, any person who violates section 301 of the FDCA with respect to food on or after the date of enactment would be liable for a civil penalty not to exceed $100,000 per violation, in the case of an individual, and $500,000 per violation, in the case of any other person. 88 These remedies would be in addition to any other remedies that would be available to FDA. 89 Each prohibited act and each day during which a violation continues would be considered a separate violation. 90 The draft bill would require FDA to consider certain factors when determining the amount of the civil penalty: (1) the 81 Section 113(b), Discussion Draft (adding section 423(d)(1)(A) to the FDCA). 82 Section 113(b), Discussion Draft (adding sections 423(d)(1)(B), (C) to the FDCA) 83 Section 113(a), Discussion Draft (adding section 301(pp)(2)(B) to the FDCA). 84 Section 113(b), Discussion Draft (adding section 423(d)(2) to the FDCA). 85 Section 113(c), Discussion Draft. 86 Pub. L , 1005, 121 Stat. 823, (2007). 87 FDCA 417(d). 88 Section 121(a), Discussion Draft (adding section 303A(a)(1) to the FDCA). 89 Section 121(a), Discussion Draft (adding section 303A(f) to the FDCA). 90 Section 121(a), Discussion Draft (adding section 303A(a)(2) to the FDCA). Page 11

12 gravity of the violation; (2) the degree of culpability of the person; (3) the size and type of business of the person; and (4) any history of prior offenses by the person. 91 FDA would be required to provide notice and opportunity for a hearing on the record in accordance with 5 U.S.C. 554 and 556 before assessing a civil penalty. 92 Amounts recovered as civil penalties would be available to FDA to cover costs of carrying out food safety activities under the draft bill. 93 The draft bill would allow a person against whom a civil penalty was assessed to file a petition for judicial review of the order. 94 This petition would have to be filed within 30 days after the effective date of the order. 95 The draft bill would require the Secretary to promptly file in the court a certified copy of the record on which the order was issued, 96 and the court could set aside the findings of the Secretary relating to the order only if the findings are found to be unsupported by substantial evidence on the record as a whole. 97 The Secretary would be permitted to refer the matter to the Attorney General if a person fails to pay a civil penalty after the order assessing the civil penalty has become a final order or after the court of appeals has entered final judgment in favor of the Secretary. 98 The validity and appropriateness of the order of the Secretary assessing the civil penalty would not be subject to review as part of the Attorney General s action to recover the civil penalty. 99 J. Miscellaneous 1. Labeling requirement for meat, poultry products, and seafood that contain carbon monoxide: Adds proposed section 201(t)(4) to the FDCA The draft bill would expand the statutory definition of color additive to include carbon monoxide when used under conditions that may impart, maintain, preserve, stabilize, fix, or otherwise affect the color of fresh meat, poultry, or seafood product unless the label of the affected food bears the following notice: CONSUMER NOTICE: Carbon monoxide has been used to preserve the color of this product. Do not rely on color or the use or freeze by date alone to judge the freshness or safety of the product. 100 This provision would take effect 30 days after enactment. 101 The draft bill would permit FDA to issue regulations establishing alternative labeling requirements after 5 years, provided that FDA makes a finding based on competent and reliable scientific evidence that the statutory consumer notice is no longer required to prevent consumer deception and other harms, and the alternative labeling requirements are shown to be effective in preventing consumer deception and 91 Section 121(a), Discussion Draft (adding section 303A(a)(4) to the FDCA). 92 Section 121(a), Discussion Draft (adding section 303A(a)(3) to the FDCA). 93 Section 121(a), Discussion Draft (adding section 303A(d) to the FDCA). 94 Section 121(a), Discussion Draft (adding section 303A(b)(1) to the FDCA). 95 Id. 96 Section 121(a), Discussion Draft (adding section 303A(b)(2) to the FDCA). 97 Section 121(a), Discussion Draft (adding section 303A(b)(3) to the FDCA). 98 Section 121(a), Discussion Draft (adding section 303A(c)(1) to the FDCA). 99 Section 121(a), Discussion Draft (adding section 303A(c)(3) to the FDCA). 100 Section 131(a)(1), Discussion Draft (adding section 201(t)(4) to the FDCA). 101 Section 131(a)(2), Discussion Draft. Page 12

13 other harms that may result under the actual conditions of use of carbon monoxide in the affected food Food substances generally recognized as safe: Adds proposed section 409(k) to the FDCA The draft bill would require the Secretary to publish a notice in the Federal Register of a request for a determination by the Secretary that a substance is a GRAS food substance. 103 FDA would be required to publish this notice no later than 60 days after receiving the request for determination. 104 The draft bill would also require FDA, no later than 90 days after publishing the notice concerning that GRAS request, to determine whether the substance is considered generally recognized as safe. 105 FDA would be required to publish in the Federal Register its determination whether the substance is generally recognized as safe. 106 It appears that this provision would create an additional process by which a substance can be determined to be GRAS rather than modifying the current processes by which these decisions are made. Currently, there are three ways to determine GRAS status: self-determination, third party certification, and submission of a GRAS notification to FDA. When a company notifies FDA of a GRAS determination and the notification provides a reasonable basis for concluding the material is GRAS, FDA will issue a letter stating that it has reviewed the notification and has no questions about the determination at this time. FDA will also make this letter available on its web site. The agency does not, however, make its own determination regarding GRAS status of the material. Should FDA disagree with the GRAS determination, it will issue a letter stating that the notification does not provide sufficient information to determine that the food contact material is GRAS. 107 The draft bill would establish a statutory procedure that FDA must follow to make a GRAS determination and would draw a clearer and more transparent line between those substances that companies have determined to be GRAS and those substances that FDA has determined to be GRAS. 3. Country of origin labeling requirements: Adds proposed section 403(z) to the FDCA The draft bill would deem a processed food misbranded under new section 403(z) of the FDCA if the labeling of the food fails to identify the country in which the final processing of the food occurs; and the website for the manufacturer of the food fails to identify the country (or 102 Section 131(b), Discussion Draft. 103 Section 132, Discussion Draft (adding section 409(k)(1) to the FDCA). The draft bill would define GRAS food substance to mean a substance excluded from the definition of the term food additive in section 201(s) because such substance is generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use. Section 132, Discussion Draft (adding section 409(k)(3) to the FDCA). 104 Section 132, Discussion Draft (adding section 409(k)(1) to the FDCA). 105 Section 132, Discussion Draft (adding section 409(k)(2) to the FDCA). 106 Section 132, Discussion Draft (adding section 409(k)(4) to the FDCA). 107 See Substances Generally Recognized as Safe, Proposed Rule, 62 Fed. Reg (Apr. 17, 1997). FDA began accepting GRAS notices in 1998, even though the proposed notification procedure has never been finalized. See About the GRAS Notification System, available at: Page 13

14 countries) of origin for each ingredient in the food. 108 In addition, the draft bill would deem misbranded a non-processed food if the labeling of the food fails to identify the country of origin of the food; and the website for the original packer of the food fails to identify the country of origin for the food. 109 FDA would be required to promulgate final regulations to implement these new misbranding provisions within 180 days after enactment and the provisions would take effect 2 years after enactment New food and animal feed export certification fee: Adds proposed section 741D to the FDCA The draft bill would add section 741D to the FDCA, which would authorize FDA to charge a fee for the issuance of export certificates for foods and animal feeds where exportation is restricted without such a certificate. 111 FDA currently collects these fees for certificates related to the export of a drug, animal drug, or device. 112 The amount of the fee would be required to be reasonably related to the cost of issuing such certificates, and the fees could be used only to pay for the costs of issuance of such certificates Dedicated Employees for Foreign Inspections: Adds proposed section 704(h) to the FDCA Under the draft bill, FDA would be required to dedicate a group of inspectors to conducting inspections of foreign food and cosmetic establishments. The draft bill would direct the Secretary to staff and fund this group at a level that would allow it to conduct inspections at a frequency that is at least equivalent to the inspection rate of domestic food and cosmetic establishments False or Misleading Reporting to FDA: Amends section 301(q)(2) of the FDCA The draft bill would amend the FDCA to prohibit the submission, on or after enactment, of any report that is required under the act with respect to any food that is false or misleading in any material respect. 115 (The FDCA currently makes this a prohibited act with regard to devices.) II. Cosmetic Safety: Adds Proposed Section 604 to the FDCA The draft bill would add section 604 to the FDCA, which would require any facility engaged in the manufacturing, processing, packing, or holding of cosmetics in the United States or for import to the United States to register with the Secretary. 116 Cosmetic manufacturers are not currently 108 Section 133(a), Discussion Draft (adding section 403(z) to the FDCA). 109 Section 133(a), Discussion Draft (adding section 403(aa) to the FDCA). 110 Sections 133(b), (c), Discussion Draft. 111 Section 134, Discussion Draft (adding section 741D(a) to the FDCA). 112 See FDCA 801(e)(4)(B). 113 Section 134, Discussion Draft (adding sections 741D(b), (c) to the FDCA). 114 Section 403, Discussion Draft (adding section 704(h) to the FDCA). 115 Section 405, Discussion Draft (amending section 301(q)(2) of the FDCA). 116 Section 301(a), Discussion Draft (adding section 604(a) to the FDCA). Because the statutory definition of cosmetic includes the finished article intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to (continued ) Page 14